The manufacture and packaging of products such as medicines or substances intended for instance for feeding a patient parenterally are generally performed in an aseptic environment. To do so, a work insolator defining a closed and sealed volume to which access is gained via an opening that is normally closed with a port in a sealed manner is typically used. Products are introduced to the inside of this work isolator by means of a shuttle isolator of relatively small size, designed so that in a sealed manner, the shuttle isolator can come alongside the opening, made for this purpose, in the work isolator. This shuttle isolator is in turn supplied from an intermediate storage isolator in which the products are sterilized.
In the current configuration, the products and materials coming from the outside are introduced via a closable opening of limited size into an isolator that is generally specialized for sterilization. After the isolator and its contents have been sterilized, the contents are transferred into a work isolator kept in a continuously aseptic state. This transfer is done either directly or by means of a shuttle isolator, but always through closable openings of limited size. Once their use is finished, the products and materials are evacuated to outside the work isolator either by the reverse process, or by other means suitable for maintaining the aseptic condition of the work isolator.
In this design, the order in which the operations inside the work isolator are performed is limited by the possibility of introducing products provided by the sterilization isolator and/or the shuttle isolator. Regardless of the number of isolators used, all the transfers are performed via closable openings, most frequently circular in shape, which open to the outside or communicate with one another; these openings are limited in size, being on the order of 500 mm in diameter, for example. These dimensional constraints impose a highly disadvantageous loading and unloading time of the isolator or isolators and require the permanent presence of two operators.
In the frequent case where the equipment includes at least one sterilization isolator and one work isolator, it is necessary under the same conditions to transfer the products from one isolator to the other, which doubles or triples the number of manipulations involved.
Equipment of this kind also has the disadvantage of being relatively complex and delicate to use, since the sterilization isolator must be continuallly re-sterilized.
In British Pat. No. 935,195, an apparatus has been proposed including a fixture connected to a rigid base, and a certain number of panels that can be deployed over the fixture, in the manner of a tent awning. The lower ends of each panel are fixed on the rectangular contour of the base by button-and-buttonhole-like fasteners. Although this structure assures easier access to the closed volume, it does so to the detriment of tightness. In particular, satisfactory tightness is unattainable even if the apparatus is provided with sealing rings between the adjacent panels and between the end of each panel and the base.